The U.S. Food and Drug Administration approved Northera
capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension
(NOH). NOH is a rare, chronic and often debilitating drop in blood pressure
upon standing that is associated with Parkinson's disease, multiple-system
atrophy, and pure autonomic failure.
Symptoms of NOH include dizziness, lightheadedness,
blurred vision, fatigue and fainting when a person stands.
The FDA is approving Northera under the accelerated
approval program, which allows for approval of a drug to treat a serious
disease based on clinical data showing that the drug has an effect on an
intermediate clinical measure (in this case, short-term relief of dizziness)
that is reasonably likely to predict the outcome of ultimate interest (relief
of dizziness during chronic treatment). This program provides patient access to
promising drugs while the company conducts post-approval clinical trials to
verify the drug’s clinical benefit, which for this approval is a long-term
effect on patient symptoms in NOH, a chronic disease.
For more information please visit: Northera
▷ View more articles...